The Difficult Airway

Completed

Conditions studied: Intubation;Difficult

In brief

Patients who are obese, as defined by a BMI ≥ 30 kg/m2 may be more difficult to intubate than non-obese patients. Traditional methods of airway assessment such as Mallampati score, mouth opening, and thyromental distance may not be the best predictors of difficult intubation. Patients who are scheduled to have non-stat surgery at Parkland Memorial Hospital will be asked to participate in this study and sign a written consent form. Physiologic measurements including but not limited to thyromental distance, sternomental distance, Mallampati score, mouth opening, interincisor distance, and mandibular protrusion will be measured and recorded. All measurements are non invasive. The remaining aspects of perioperative care, including the general anesthetic technique, will be standardized for all patients and will not differ from the standard of care. There will be no incentive or payment to the patients. This prospective study is intended to enroll 4500 consecutive surgical patients. Lean patients (BMI \< 30 kg/m2) who are intubated by the same anesthesia providers during the same time period will be included as the control group and to report the incidence of difficult mask ventilation and difficult intubation in our general surgical population, which has not previously been defined.

Key facts

Study ID

NCT03671824

Run by

University of Texas Southwestern Medical Center

People needed

4022

Starts

2016-06-01

Expected to finish

2019-12-01

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-80 years old
• ASA physical status classification 1 to 4
• Scheduled for an operation that requires general endotracheal anesthesia
• Willing and able to consent in English or with use of appropriate language translator
• Anesthesia providers who are caring for patients who have enrolled in the study will also be potential subjects who will be verbally consented and asked to fill out a questionnaire.

You may not qualify if…

• Age less than 18 or older than 80
• Unable to give informed consent for participation in the study
• Stat cases
• Patients who will not be expected to have general anesthesia (e.g., monitored anesthesia care or regional anesthesia)
• Patient refusal
• History of difficult intubation
• Planned awake fiberoptic intubation
• Previous neck surgery (on bone, joint, or soft tissues in neck) or radiation
• Obvious neck pathology/abnormality

Where it is running

• Parkland Health & Hospital System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.